Manager Corporate Drug Regulatory Affairs (12 month agency contract)

Viatris; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Viatris is seeking a Manager Corporate Drug Regulatory Affairs in Dublin, Ireland to lead regulatory applications and ensure compliance across global markets. This role requires a strong educational background in natural sciences, excellent communication skills, and the ability to work within cross-functional teams.

You will handle various regulatory documentation and support quality assurance activities. Join Viatris for a chance to make a global impact on healthcare accessibility.

Qualifications

• University degree in natural sciences, i.e. Biology, Chemistry or Pharmacy.
• Knowledge of essential regulatory requirements.
• Ability to plan and execute regulatory projects globally.
• Excellent communication skills, a real team player.
• Excellent skills in English language.
• Knowledge of standard EDV programs (e.g. MS-Office).
• Preferable knowledge in common regulatory systems.

Responsibilities

• Handle marketing authorisation application procedures worldwide.
• Prepare and discuss licensing strategies with authorities.
• Collaborate in regional/global projects in cross-functional teams.
• Review and prepare regulatory documents.
• Coordinate quality documentation and clinical/non-clinical documentation.
• Support QA and pharmacovigilance activities.
• Use electronic systems for regulatory management.

Skills

Regulatory requirements knowledge

Project planning and execution

Excellent communication skills

Team player

Fluent English

Knowledge of standard EDV programs

Knowledge of regulatory systems

Education

University degree in natural sciences (Biology, Chemistry, Pharmacy)

Tools

MS-Office

Document management system

Change Control System

Regulatory Information Management System

Job description

Overview

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Manager Corporate Drug Regulatory Affairs role will make an impact:

• Handling of marketing authorisation application procedures (e.g. new submissions, line extensions) worldwide, as well as registration maintenance activities (e.g. variations, renewals)
• Preparation and discussion of licensing strategies with national and international authorities
• Collaboration in regional / global projects in Cross functional teams
• Review, preparation, coordination and processing of regulatory documents (CTD-module 1)
• Review and coordination of quality documentation (CTD – module 3 / 2.3)
• Coordination of clinical and non-clinical documentation
• Support of QA activities (e.g. change control, PQR), drug information and
• pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs)
• Use of electronic systems like Documenten management system, Change Control System, Regulatory Information Management System, etc.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• University degree in natural sciences, i.e. Biology, Chemistry or Pharmacy
• Knowledge of essential regulatory requirements
• Ability to plan and execute regulatory projects globally
• Excellent communication skills, a real team player
• Excellent skills in English language
• Knowledge of standard EDV programs (e.g. MS-Office)
• Preferrable knowledge in common regulatory systems (e.g. DMS, CCS, RIMS)

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.